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欣諭XY-FD-S10E真空冷凍干燥機（冰凍干燥機）制造標準 Manufacture Standards			cGMP
A、干燥箱（含1.08m²板層） Chamber (with1.08m² shelves)
序號SN	名稱 Name	型號/規格/材質 Model/Specifications/Material	數量 Number
1	干燥箱 Chamber	AISI 316L 不銹鋼	1套
2	板層 Shelves	AISI 316L 不銹鋼	1套
		尺寸：600×450×20mm Dimensions：600×450×20mm	4+1層
3	箱門 Door	部分AISI 316 不銹鋼 Part AISI 316 stainless steel	1套
4	干燥箱視鏡 Viewing port (chamber)	DN-200 mm 帶延時照明燈 DN-200 mm With time delay head lamp	1個
5	箱門視鏡 Viewing port (door)	DN-200 mm	1個
6	驗證孔 Validation port		1個
7	手動門鎖系統 Door lock system with safe	蝶形手柄設計 The butterfly handles	1套
8	制品測溫探頭 Product sensors	Pt-100 熱電阻 A級 Pt-100 Hot resistance A Level	3支
9	導熱油溫度探頭 Temperature sensors (thermal fluid)	Pt-100 熱電阻 A級 Pt-100 Hot resistance A Level	2支
性能參數 Performance parameters
1	設計壓力 Design pressure	常壓 Normal pressure
2	設計溫度 Design temperature	常溫 Normal temperature
3	光潔度 Finish	Ra≤0.5µm
4	平整度 Level	±1mm/m
5	板層Z低溫度(導熱油進口) Shelves temperature Min	-50℃
6	板層Z高溫度(導熱油進口) Shelves temperature Max	+70℃
7	板層溫度均勻性 Shelves temperature uniformity	±1°C（空載平衡后） ±1°C（soak stage）
8	擱板間距 Spacing	100mm
9	干燥箱外形 Chamber type	長方型 Rectangular
10	保溫層 Insulation	硅酸鋁和聚氨酯發泡材料 Aluminum silicate and polyisocyanurate foam
11	開門方向 Open direction	根據用戶要求確定 According to user’s requirements
12	開門角度 Open angle	大于110度 More than 110°
13	視鏡方向 Position of viewing port	根據用戶要求確定 According to user’s requirements
14	門密封條 Sealing strips for doors	O型硅橡膠 O-shaped silicone rubber
技術優勢 Technical advantages
1	不銹鋼板材均采用優質板材，保證箱體表面光潔度，從而保證無菌要求； Stainless steel plates are superior. Ensure the finish of chamber surfaces, and then ensure the asepsis requirement.
2	板層具有很高強度，能夠耐受長期使用； Shelves has high intensity and its maximum valve reaches to 0.3Mpa in the pressure test which can be able to bear the long term usage.
3	板層通過機械加工，可保證高要求平整度； Shelves are processed by machining which can ensure the demanding level.
4	板層控溫精度±0.5℃（PID調節）； Temperature control accuracy±0.5℃ (adjusted by PID)
6	箱體、板層、軟管均采用氦質譜儀進行泄漏檢驗； Chamber, shelves, flexible hoses are all carried out the leak test by helium mass spectrometer.
B、冷凝器（含盤管） Condenser (with coiled pipe)
序號 SN	名稱 Name	型號/規格/材質 Model/Specifications/Material	數量 Number
1	冷凝器 Condenser	AISI 316L不銹鋼	1套
2	冷凝盤管 Condenser coiled pipe	AISI 316L 不銹鋼	1套
4	視鏡 Viewing port	DN-150mm 帶延時照明燈 DN-150 mm With time delay head lamp	1個
5	冷凝器測溫探頭 Temperature sensors (condenser)	Pt-100 熱電阻 A級 Pt-100 Hot resistance A Level	2支
6	化霜噴球 Spray ball for de-icing	AISI 316L 不銹鋼	2個
性能參數 Performance parameters
1	設計壓力 Design pressure	常壓Normal pressure
2	設計溫度 Design temperature	常溫Normal temperature
3	光潔度 Finish	Ra≤0.5um
4	盤管Z低溫度 Coiled temperature Min	≤-70℃
5	冷凝器捕冰能力 Condenser frosting capacity	60Kg/批 60Kg/batch
6	冷凝器外型 Condenser type	長方型 Rectangular
技術優勢 Technical advantages
1	不銹鋼板材均采用優質板材，保證箱體表面光潔度，從而保證無菌要求； Stainless steel plates are superior. Ensure the finish of chamber surfaces, and then ensure the asepsis requirement.
2	冷凝器、盤管采用氦質譜儀進行泄漏檢驗； Condenser and coiled pipe are all carried out the leak test by helium mass spectrometer.
C、蘑菇閥 Mushroom valve
序號 SN	名稱 Name	型號/規格/材質 Model/Specifications/Material	數量 Number
1	蘑菇閥mushroom valve	AISI 316 不銹鋼 AISI 316 stainless steel	1套
2	蘑菇閥油缸 mushroom valve cylinder	上海“晶盛"30/80 Shanghai“jingsheng" 30/80	1個
性能參數 Performance parameters
1	工作動力 Motivation	液壓驅動 Hydraulic driven
2	蘑菇閥尺寸 Mushroom valve dimension	DN-250mm
技術優勢 Technical advantages
1	蘑菇閥球頭采用模壓制造，球頭表面光潔易清洗； The head of mushroom valve is manufactured by molding, the head surface is glabrous and easy clean.
2	蘑菇閥可通過減壓閥進行調整，防止關閉壓力過大； Mushroom valve can be adjusted by reducing valve to prevent the over closing pressure.
3	蘑菇閥的“打開"或“關閉"具有反饋信號，能夠真實的了解工作狀態； When mushroom valve is ON or OFF there is a feedback signal which can be in favor of knowing the working state truly.
4	新型蘑菇閥板法蘭采用二次加工，具有很高的密封性和準確性，可*防止內泄漏； New-fashioned plate flange of mushroom valve is used the secondary process which has very high sealing quality and accuracy. These can thoroughly prevent the inside leak.
D、制冷系統 Refrigeration system
序號 SN	名稱 Name	型號/規格/材質 Model/Specifications/Material	數量 Number
1	壓縮機型號及數量 Compressor model and number	BITZER“比澤爾"S4G-5.2Y	1臺
2	制冷劑 Refrigerant	R404a 綠色環保型 R404a Environment Friendly	適量 Right quantity
3	油分離器 Oil separator	Emerson	1個
4	回氣過濾器 Filter for return air	Emerson	1個
5	油壓差控制器 Oil differential pressure controller	丹麥 DANFOSS	1個
6	油平面視鏡 Viewing port (oil level)	丹麥 DANFOSS	1個
7	壓力自動保護裝置 Automatic protective device for pressure	FNC KOREA	1個
8	自動收液裝置 Automatic liquid recycling device	FNC KOREA	1個
9	氣液分離器 Gas-liquid separator	DANHUA	1個
10	除酸干燥過濾器 Filter for disacidifying and drying	外殼Emerson，濾芯Emerson Shell Emerson，Filter Core Emerson	1套
11	壓力表 Pressure meter	ARRON	4個
12	頂蓋閥 Tectum valve	意大利 CASTEL	1個
13	繼電器 Relay	ARRON	1個
14	膨脹閥 Expansion valve	丹麥 Danfoss	3個
15	電磁閥 Solenoid valve	丹麥 Danfoss	5個
16	低壓避震管 Low-pressure vibration absorber	美G YORK PA	1套
17	高壓避震管 High-pressure vibration absorber	航天“晨光"	1套
性能參數 Performance parameters
1	板層制冷速度（空載）（擱板進口） Shelf cooling time (empty)	+20 ～ -40°C ≤ 60 minutes
2	冷凝器制冷速度（空載） Condenser cooling time (empty)	+20 ～ -40°C ≤ 30 minutes
技術優勢 Technical advantages
1	壓縮機采用“比澤爾"機組，性能更加穩定、可靠； Adopting the BITZER compressor makes the performance be more stable and relibale.
2	采用符合蒙特利爾公約的環保型制冷劑； Adopt the environmental protection type refrigerant which accords with the Montreal Convention.
3	制冷系統具有各項保護功能，連鎖保護； The refrigeration system has all kinds of protection functions and interlock protection.
①	凍干后期低負荷條件下的壓力自動調整功能； The automatic adjustment function of pressure under the condition of low load in the late of freeze drying period.
②	制冷系統油壓壓力多重保護功能； The poly-protection function of oil pressure in the refrigeration system.
③	壓縮機電機多重保護功能； The poly-protection function of compressor motor
E、真空系統 Vacuum system
序號 SN	名稱 Name	型號/規格/材質 Model/Specifications/Material	數量 Number
1	真空泵Vacuum pump	ULVAC VDN401	1臺
2	泵阱隔離閥Isolation valve of pump well	DN-50mm	1個
3	泵頭閥Pump head valve	西瑪特 SIEGV	2個
4	真空探頭Vacuum gauge	英G“愛德華"EDWARDS APG	2個
性能參數 Performance parameters
1	J限真空Final vacuum	≤5Pa
2	抽氣速度Evacuation time	從大氣壓抽至10pa≤30min From atm to 10pa≤30min
3	泄漏率Leakage rate	5×10^-3pa.m³/sec
技術優勢 Technical advantages
1	GX泵頭閥與真空泵同時打開和關閉，可大大防止真空泵油逆向擴散； The efficient pump head valve and vacuum pump start or close simultaneously. These can prevent the vacuum pump oil from spreading in reverse effectively.
F、復壓摻氣系統 Aeration system for repressing
序號 SN	名稱 Name	型號/規格/材質 Model/Specifications/Material	數量 Number
1	過濾器Filter	0.22µm	1個
2	摻氣閥Aeration valve	西瑪特 SIEGV	1個
4	管道Pipeline	AISI 316不銹鋼	1套
技術優勢 Technical advantages
1	管道全部采用自動焊接，保證內外壁光潔； All the pipelines use the automatic welding which will ensure the finish of inner and outer surface.
2	復壓系統預留了可進行充氮氣接口； A interface by which it can inject nitrogen reserves in the repressing system.
G、循環系統 Circulation system
序號 SN	名稱 Name	型號/規格/材質 Model/Specifications/Material	數量 Number
1	循環泵 Circulation pump	德G“威樂" WILO TOP-SD32-7	1臺
2	導熱油 Thermal fluid	低粘度硅油 Silicon oil (low viscosity)	適量 Right quantity
3	電加熱 Heater	2Kw	1支
4	板式熱交換器Plate heat exchanger	瑞典“阿法拉伐" ALFALAVAL 技術	2個
5	導熱油測溫探頭 Temperature sensors(thermal fluid)	Pt-100 熱電阻 A級 Pt-100 Hot resistance A Level	2支
6	溫度控制器 Temperature controller	丹麥“丹佛斯"DANFOSS	1個
7	壓力控制器 Pressure controller	丹麥“丹佛斯"DANFOSS	1個
性能參數 Performance parameters
1	加熱速度Heating rate	1°C/min
2	硅油粘度 Silicon oil viscosity	5cSt 25℃
技術優勢 Technical advantages
1	電加熱采用PID能量調節控制，可以Z有效的利用加熱能源； Electric heating is